NIPH Clinical Trials Search

UMIN ID: C000000117

Registered date:06/09/2005

Phase 3 study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedelderly patients with advanced non-small cell lung cancer
Date of first enrollment2000/05/01
Target sample size180
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)docetaxel 60 mg/m2 on day 1,repeated every 21 days over four cycles vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles.


Primary OutcomeOverall survival
Secondary Outcomesafety,efficacy,QOL

Key inclusion & exclusion criteria

Age minimum70years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPatients with symptomatic brain metastasis or apparent dementia were ineligible. Patients with active concomitant malignancy, massive pleural effusion or asites, active infection, severe heart disease, grade 2 or higher ECG abnormality, uncontrolled diabetes mellitus, ileus, pulmonary fibrosis, diarrhea, and a bleeding tendency were excluded.

Related Information


public contact
Name Shinichiro Nakamura
Address Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Shinzoh Kudoh, MD
Address 1-4-3, Asahimachi, Abeno-ku, Osaka, Japan, 545-8585 Japan
Affiliation Osaka City University Medical School Department of Respiratory Medicine